CARAMAL - Community Access to Rectal Artesunate for MALaria

Project Abstract

Malaria is one of the leading causes of illness, death, and lost economic productivity globally. While the successful scale-up and use of critical commodities such as insecticide-treated nets (ITNs) and artemisinin-based combination therapies (ACTs) have led to a 62% decline in malaria-related mortality between 2000 and 2015, malaria still results in over 400,000 deaths each year, most of which are in children under 5 years of age and pregnant women. The heaviest malaria burden continues to be borne by sub-Saharan African countries which accounted for an estimated 90% of malaria cases and 92% of malaria deaths in 2015.

Many episodes of severe malaria occur in remote locations in which access to health services is limited, treatment for severe malaria, particularly parenteral therapy is not available, and long delays in referring patients to an appropriate health facility are common. Without effective pre-referral treatment that can be administered at the community level, many cases of severe malaria will result in death.

Where parenteral treatment of severe malaria is not available, the World Health Organization (WHO) recommends treating children less than 6 years old with a single rectal dose of 10 mg artesunate per kilogram of body weight prior to referral. It rapidly (i.e. within 24 h) clears 90% or more of malaria parasites and in children less than 6 years old who cannot reach a facility in less than six hours, it can reduce the risk of death or permanent disability by up to 50%. After the administration of rectal artesunate (RAS), the child should be referred immediately to an appropriate facility where the full package of care for severe malaria can be provided.

Currently, 16 countries in Africa have included the use of pre-referral RAS in their treatment policies, but guidelines for use vary widely across these countries and often they do not align with the WHO recommendation. Widespread use of this product without alignment with WHO recommendations raises substantial concerns, including regarding its inappropriate use as a monotherapy against both severe and uncomplicated malaria.

With the impending availability of quality-assured rectal artesunate (QA RAS) and countries poised to scale-up this intervention, it is critical to investigate the safe and effective implementation of RAS in existing community-based case management systems, as part of a continuum of care for severe malaria patients. The pilot roll-out of QA RAS in the Democratic Republic of the Congo (DRC), Nigeria and Uganda provides a unique and timely opportunity to generate high-quality evidence applicable to a wide range of African settings.

Accompanying the pilot roll-out of QA RAS by UNICEF, the CARAMAL project will test whether it is feasible to introduce QA RAS into established integrated community case management (iCCM) platforms with only minimal additional supportive interventions and with minimal unintended consequences such as inappropriate use as artemisinin monotherapy.